OncoMatch/Clinical Trials/NCT04128748
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
Is NCT04128748 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Liposome-encapsulated Daunorubicin-Cytarabine and Quizartinib for acute myeloid leukemia.
Treatment: Liposome-encapsulated Daunorubicin-Cytarabine · Quizartinib — This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy for AML or MDS — relapsed or refractory cohort
For relapsed or refractory cohort: Patients who have received at least one prior therapy for AML or for MDS (with > 10%) blasts will be eligible. Patients may have received up to 4 salvage regimens for AML and/or MDS
Cannot have received: chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis)
Exception: hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis; transfusions, hematopoietic growth factors, vitamins, apheresis, ATRA, steroids, supportive care therapy for MDS
For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis) for AML or MDS. They may have received transfusions, hematopoietic growth factors or vitamins for an antecedent hematological disorder (AHD) or for AML. Temporary prior measures such as apheresis, ATRA (all-trans retinoic acid), steroids or hydrea while diagnostic work-up is being performed are allowed and not counted as a prior salvage. Supportive care therapy for MDS (growth factors, transfusions) will not be considered as prior therapy for MDS/AML and these patients will be enrolled to the frontline cohort of the study if they are otherwise eligible
Lab requirements
Kidney function
Creatinine < 1.8 mg/dl
Liver function
Total bilirubin < 1.8 mg/dL, unless increase is due to hemolysis or congenital disorder; Transaminases (SGPT) < 2.5x ULN
Cardiac function
Baseline left ventricular ejection fraction by ECHO or MUGA >= 50%
Serum biochemical values with the following limits unless considered due to leukemia * Creatinine < 1.8 mg/dl * Total bilirubin < 1.8 mg/dL, unless increase is due to hemolysis or congenital disorder * Transaminases (serum glutamate pyruvate transaminase [SGPT]) < 2.5x upper limit of normal (ULN) * Potassium, magnesium, and calcium (normalized for albumin) levels should be within institutional normal limits * Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition scan (MUGA) >= 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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